PENTRA 120 and PENTRA 120 Retic Hematology Analyzer
FDA Recall Z-1342-04 · Posted 2004-08-13
Recalling FirmABX Diagnostics Inc
Recall StatusTerminated
Product CodeGJH
Date Initiated2004-06-24
Date Terminated2005-09-02
Product Quantity81
Reason for Recall
Power failure having impact on software.
Firm Action
Firm sent a notification / recall letter and response card dated June 24,2004 and promised to provide software shortly.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.